Miller Galante II CP0001912

GUDID 00887868347832

Biomet Orthopedics, LLC

Tibial insert

• Primary Device ID: 00887868347832
• NIH Device Record Key: 56eed0e8-824e-4c56-be1c-8fe0d33e980b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miller Galante II
• Version Model Number: CP0001912
• Catalog Number: CP0001912
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868347832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K892800

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-27
• Device Publish Date: 2020-01-17

On-Brand Devices [Miller Galante II]

• 00887868347856: CP0001914
• 00887868347849: CP0001913
• 00887868347832: CP0001912